In the face of the existing HIV-1 epidemic, an effective mix of prevention modalities are needed to begin to reduce the incidence of HIV-1. This includes the used of topical microbicides. These are products that would be used to prevent the sexual transmission of HIV-1;including receptive anal intercourse. Project 1, Nonclinical Strategies for Refining Combination Rectal Formulations, of this U19 will strive to ensure that a safe and effective rectal microbicide will be developed. To date, the Phase 2b trials of

Public Health Relevance

HIV-1 infection is a devistating disease that is mostly spread through sexual activity. Because of the high likelihood that a couple will participate in anal sex without a condom, we need to prevent possible HIV-1 infection through the rectum. To do this, rectal microbicides (products that kill HIV-1) are being developed to use just before or just after anal sex.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
3U19AI082637-04S1
Application #
8720896
Study Section
Special Emphasis Panel (ZAI1-BP-A)
Project Start
2012-09-01
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
4
Fiscal Year
2013
Total Cost
$64,603
Indirect Cost
Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
119132785
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Mcgowan, Ian; Cranston, Ross D; Duffill, Kathryn et al. (2015) A Phase 1 Randomized, Open Label, Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Three Formulations of Tenofovir 1% Gel (the CHARM-01 Study). PLoS One 10:e0125363
Hiruy, Hiwot; Fuchs, Edward J; Marzinke, Mark A et al. (2015) A Phase 1 Randomized, Blinded Comparison of the Pharmacokinetics and Colonic Distribution of Three Candidate Rectal Microbicide Formulations of Tenofovir 1% Gel with Simulated Unprotected Sex (CHARM-02). AIDS Res Hum Retroviruses 31:1098-108
Hladik, Florian; Burgener, Adam; Ballweber, Lamar et al. (2015) Mucosal effects of tenofovir 1% gel. Elife 4:
Dezzutti, Charlene S; Russo, Julie; Wang, Lin et al. (2014) Development of HIV-1 rectal-specific microbicides and colonic tissue evaluation. PLoS One 9:e102585
McGowan, Ian; Dezzutti, Charlene (2014) Rectal microbicide development. Curr Top Microbiol Immunol 383:117-36
McGowan, Ian (2014) The development of rectal microbicides for HIV prevention. Expert Opin Drug Deliv 11:69-82
Wahl, Angela; Victor Garcia, J (2014) The use of BLT humanized mice to investigate the immune reconstitution of the gastrointestinal tract. J Immunol Methods 410:28-33
Rohan, Lisa C; Yang, Haitao; Wang, Lin (2013) Rectal pre-exposure prophylaxis (PrEP). Antiviral Res 100 Suppl:S17-24
Chateau, Morgan L; Denton, Paul W; Swanson, Michael D et al. (2013) Rectal transmission of transmitted/founder HIV-1 is efficiently prevented by topical 1% tenofovir in BLT humanized mice. PLoS One 8:e60024
Chateau, Morgan; Swanson, Michael D; Garcia, J Victor (2013) Inefficient vaginal transmission of tenofovir-resistant HIV-1. J Virol 87:1274-7

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